ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

NCT07673627 · tracked via the Priya Life Science USA tracker

Sponsor

argenx

Phase

Phase 2

Started

2026-07-10

Last updated

2026-08-21

Condition(s) studied

AChR-Ab Seropositive Generalized Myasthenia GravisMyasthenia Gravis (MG)MG - Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Empasiprubart IVPlacebo IVEfgartigimod PH20 SC PFS

Empasiprubart IV: Intravenous infusions of empasiprubart

Placebo IV: Intravenous infusions of placebo

Efgartigimod PH20 SC PFS: Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

Study summary

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

The aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward2

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab). * Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb. * Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration. Exclusion Criteria: * Clinical diagnosis of systemic lupus erythematosus (SLE). * Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \>2 months or ravulizumab \>6 months before baseline are allowed to participate. * Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline. * Had prior empasiprubart exposure.

Primary outcome measure(s)

Incidence of adverse events and serious adverse events in the DBTP — Up to 12 weeks

Trial sites (3)

Facility	City	Region	Status
Visionary Investigators Network	Miami	Florida	Recruiting
Dent Neurologic Institute - Amherst	Amherst	New York	Recruiting
Erlanger Health System	Chattanooga	Tennessee	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07673627 on ClinicalTrials.gov ↗ ← All trials in the USA